Judge Favors FDA in “Generally Recognized as Safe” Rule Dispute

In a Thursday ruling, a Southern District of New York judge sided with the Food and Drug Administration in upholding what is known as the “Generally Recognized as Safe,” or GRAS, rule. The plaintiffs, the Center for Food Safety and the Environmental Defense Fund, argued that the rule represented an unlawful subdelegation of agency duties, and exceeded statutory authority provided by the Federal Food, Drug, and Cosmetic Act.

Key to the case is a 1958 law which requires the FDA to approve “food additives,” except those generally recognized as safe by experts. Over time, the opinion explained, this exemption turned into today’s GRAS rule, a “‘notification procedure whereby any person may notify [the FDA] of a conclusion that a particular use of a substance is GRAS.'” This rule requires that applicants provide scientific reasoning for their determination. The FDA responds to the submission within months, the opinion said.

The opinion rejected the plaintiff’s first argument, that “the GRAS Rule ‘unlawfully subdelegates—or shifts—to manufacturers this core governmental duty, allowing them to decide for themselves, in secret, whether the chemical substances they have synthesized may be added to food.'” The judge found that the plaintiff raised “legitimate concerns,” but sided with the FDA because the agency retains the ability to reject GRAS applications and bring enforcement actions. The judge added that the statute does not require the food additive approval process to be subject to court challenge.

In a similar manner, the judge rejected the Administrative Procedures Act claim that the FDA acted arbitrarily and capriciously, finding that the agency action passed muster under the Chevron standard.

The plaintiff was represented by their own counsel, as well as Earthjustice.

George Kimbrell, legal director for the Center, said in a press release that “We are extremely disappointed by the court’s ruling that will continue to allow FDA to flout its regulatory duties and outsource the job to self-interested food corporations driven by their bottom line rather than the public interest. 

“We are carefully reviewing the decision and considering all legal options, including appeal.”